BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOLET 2

    MDR report key: 15417 · Received August 22, 1994

    Report

    Report Number
    MW1003149
    Event Type
    Malfunction
    Date Received
    August 22, 1994
    Date of Event
    August 11, 1994
    Report Date
    August 11, 1994
    Manufacturer
    MILES, INC.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DART ON AUTOMATIC LANCING DEVICE FAILED TO RECESS AFTER USE. PUNCTURE OF EMPLOYEE WHEN PICKING UP IMPLEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOLET 2 LANCING DEVICE FMK MILES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other